NeuroBlate Optic FullFire® Laser Probe 20893-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00816589020953), received between Apr 19, 2019 and Oct 24, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2023Contamination; Contamination

  THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY 29 DAYS POST LITT PROCEDURE. PER LAANTERN REGISTRY INFORMATION, A BIOPSY WAS PERFORMED THE SAME DAY AS LITT PROCEDURE. ACCORDING TO A LAANTERN REGISTRY AE FORM ENTERED ON (B)(6) 2023, THE PATIENT WAS "TRANSFERRED FROM OUTSIDE HOSPITAL FACILITY COMPLAINT OF DIZZINESS, SLURRED SPEECH, MEMORY LOSS, AND UNSTEADY GAIT FOR 2 DAYS. ALSO ENDORSED INCISION SITE PAIN AND SWELLING" ON (B)(6) 2023. INTERVENTIONS INCLUDED HOSPITALIZATION STARTING ON (B)(6) 2023 (DISCHARGE DATE NOT REPORTED), SURGICAL INTERVENTION OF LEFT SIDED CRANIAL WOUND WASHOUT AND MESH CRANIOPLASTY, PICC LINE PLACEMENT, AND ANTIBIOTIC THERAPY (PER PROVIDED SOURCE DOCUMENTATION). PER THE (B)(6) 2023 WOUND WASHOUT AND MESH CRANIOPLASTY OPERATIVE NOTE FINDINGS, "FRANK PURULENCE IN SUBGALEAL SPACE AND INTRADURAL SPACE" WAS NOTED.

  Patient problems: Bacterial Infection

  MAUDE report 17993396 ↗
• MalfunctionJun 28, 2023Radiation Leak; Radiation Leak

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT A LASER PROBE WAS DAMAGED AND THE PILOT LIGHT WAS SEEN EXITING NEAR THE CONNECTOR. THE LASER PROBE WAS NOT USED DURING THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221319 ↗
• MalfunctionJun 5, 2023Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE LASER FIBER WAS DAMAGED (THERMALLY FUSED) AT THE PORTABLE CONNECTOR MODULE (PCM) CONNECTION TO THE DISPOSABLE LASER FIBER. THERE ARE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060956 ↗
• MalfunctionMay 10, 2023Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN STARTED PRESSING THE FOOT PEDAL ONCE HE WAS READY TO ABLATE. AFTER A FEW ACQUISITIONS, THE CLINICAL SPECIALIST NOTICED THAT THERE WAS NO HEAT OBSERVED IN THE THERMAL MASK. THE CLINICAL SPECIALIST SUGGESTED TO THE PHYSICIAN TO STEP OFF THE PEDAL AND WENT TO INVESTIGATE. UPON ENTERING THE MRI SUITE TO CHECK THE E2K CONNECTION BETWEEN THE LASER AND THE PORTABLE CONNECTOR MODULE (PCM), THE CLINICAL SPECIALIST TRIED TO UNPLUG AND RE-PLUG THE LASER FIBER BUT WAS UNSUCCESSFUL. WHEN ATTEMPTING TO UNPLUG THE LASER FIBER FROM THE E2K CONNECTION, THE ORANGE TAB OF THE LASER FIBER BROKE OFF. AT THIS TIME, THE CLINICAL SPECIALIST GATHERED THE CABLE AND THE FOUND THAT THE E2K-TO-E2K CONNECTION OF THE PCM AND THE FIBER WAS FUSED. GIVEN THE SITUATION, A NEW FIBER WAS OBTAINED AND THE PCM WAS REPLACED WITH A NEW ONE. AFTER DOING SO, THE ABLATION PROCEDURE WAS RESUMED AND THE LESION WAS SUCCESSFULLY ABLATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904083 ↗
• MalfunctionJul 20, 2022Radiation Leak; Radiation Leak

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE USER NOTICED THE PROBE WAS NOT HEATING WHILE FIRING THE LASER. THE CLINICAL SPECIALIST WENT INTO THE MRI ROOM TO CHECK THE CONNECTIONS AND DISCOVERED THE PROBE'S LASER FIBER WAS DAMAGED AND WAS WARM TO THE TOUCH AT THE LOCATION OF THE DAMAGE. UPON DISCOVERY OF THE DAMAGE, THE LASER LIGHT WAS SHINING THROUGH DAMAGED AREA OF CABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064567 ↗
• MalfunctionOct 15, 2020Melted; Output Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE USER HAD BEEN STEPPING ON PEDAL TO ACTIVATE LASER, BUT NO TDT LINES WERE FORMULATING. THE ATTENDING CLINICAL SPECIALIST TOLD USER TO STOP AND WENT INTO MRI ROOM AND NOTICED WHITE PROBE CABLING WAS BURNT. THE USER WAS ABLE TO PROCEED WITH THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10683237 ↗
• MalfunctionJun 15, 2020Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE USER NOTICED THAT THERE WAS DAMAGE TO THE PROBE FIBER. IT WAS NOTED THAT THERE WAS A PILOT LIGHT SEEN ON INSERTION BUT WHEN THE USER WENT TO ADMINISTER THERAPY, THREE DIFFERENT TIMES, NO CHANGE IN IN PIXEL COLOR (TEMPERATURE) WAS NOTICED. ALL BREAK POINTS IN THE FIBER LINE WERE CHECKED FOR SECURE ATTACHMENT AND A DUMMY (UN-STERILE) PROBE WAS USED TO PROVE THAT WE SOMEHOW HAD A FAULTY PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10154942 ↗
• MalfunctionOct 23, 2019Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, UPON PLUGGING IN THE PROBE, IT WAS NOTED THAT THE INDICATOR LIGHT WAS VERY DIM. THE SURGEON DID NOT WANT TO USE THE PROBE. ANOTHER PROBE WAS USED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9226687 ↗
• MalfunctionApr 19, 2019Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE PROBE MIGHT HAVE CRACKED ALONG THE CABLING DURING THE PATIENT TRANSPORT. THE USER PLACED THE PROBE IN THE OPERATING ROOM AND THEN TRANSPORTED THE PATIENT WITH THE PROBE INSERTED TO THE MRI. IT WAS ALSO NOTED THAT THE CLINICAL SPECIALIST (CS) WENT IN THE ROOM TO CHECK THE LASER PROBE AND THERE WAS A VISIBLE BURN ON THE PROBE CABLING BEHIND THE YELLOW DEPTH LOCK. THE CS CHECKED ALL OF THE LASER FIBER CONNECTIONS FROM THE RACK TO THE PANEL AS WELL AS THE PANEL TO THE PORTABLE CONNECTOR MODULE (PCM) TO MAKE SURE THAT THE FIBER CONNECTIONS WERE PLUGGED IN SECURELY. ALL CONNECTED LOOKED SECURE. THE CLINICAL SPECIALIST SWITCHED OUT THE PROBE AND CONTINUED THE CASE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8533058 ↗